FDA Issues Guidance on Drug Development Tools Qualification Process

Sponsors voluntarily submitting drug development tools (DDTs), such as biomarkers and clinical outcomes assessments, to the FDA will have to undergo a new qualification process, according to a draft guidance from the agency.

The draft guidance divides DDTs into three buckets: biomarkers, clinical outcomes assessments and animal models. Once the FDA has qualified a DDT, it can be used in future trials without additional reviews.

This guidance replaces a 2014 draft guidance of the same name and follows another draft guidance issued in December 2018 that helps researchers produce valid biomarkers.